INFINITI 534617TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032014151), received between Feb 12, 2021 and Feb 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K970854); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2021Crack; Device Contamination with Chemical or Other Material; Crack; Device Contamination with Chemical or Other Material

  PRIOR TO OPENING A PACK OF 6F 100CM JUDKINS LEFT 4.5 (JL4.5) INFINITI CATHETER, THE TECH NOTICED MULTIPLE PIECES OF THE BLUE CATHETER LAYING LOOSE IN THE PACK. THE PRODUCT WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR IS TRAINED TO USE THE DEVICE. THE DEVICE WAS NOT OPENED IN A STERILE FIELD. THE LOOSE BLUE PIECES WERE FOUND INSIDE THE STERILE PACKAGING OF ONE, SINGLE CATHETER, WHERE NO COMPROMISE TO THE PACKAGE WAS NOTED. THE STERILE PACKAGING ON THE OTHER 3 DEVICES HAD NO NOTED COMPROMISE TO STERILE PACKAGING EITHER. THE PRODUCT WAS NEVER OPENED. THE DEVICES THEMSELVES WERE INTACT. THE CATHETERS WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) AND HANG ON PEGS ON THE CATHETER RACK IN THE LOCKED, SECURED LAB. THE DEVICES ARE TAKEN STRAIGHT TO THE LAB AS SOON AS THEY ARE RECEIVED. THE SHIPPING BOX WAS NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION TOGETHER WITH 3 UNUSED DEVICES WITH THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324375 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970854. One submission often covers many models, so check the product and lot details in each record.

• Z-0286-2024 · Sep 26, 2023 · Open, Classified
  Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
• Z-0720-2023 · Nov 7, 2022 · Open, Classified
  Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
• Z-1240-06 · Jun 26, 2006 · Terminated
  Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T